Uterine specimen collecting method

ABSTRACT

A specimen collecting method comprises an elongate clincical instrument having a blade and handle for collecting cells and tissues from body cavities, particularly for the detection of squamous carcinoma of the cervix. Two slanted spaced-apart edges on the blade tip describe a conical path during manual rotation in situ and gather specimens in troughs adjoining the edges. The blade tip is manually separable from the handle for forwarding to a pathology laboratory.

United States Patent, 11 1 McDonald Nov. 27, 1973 [54] UTERINE SPECIMENCOLLECTING 3,352,299 11/1967 Sagirogh 128/2 B METHOD 3,394,699 7/1968Koett 128/2 B [76] Inventor: Bernard McDonald, 18212 Pacific Coast Hwy.,Malibu, Calif. 90265 Primary Examiner-William E. Kamm Filed: June 1971Att0rneyEdward H. Loveman Appl. No.: 155,513

Related US. Application Data Continuation-impart of Scr. No. 24,535,April 1, 1970, Pat. No. 3,633,565.

US. Cl. 128/2 B Int. Cl. A6lb 19/00 Field of Search 128/2 B, 2 F, 2 R,

References Cited UNITED STATES PATENTS 9/1959 Nieburgs 128/2 B [57]ABSTRACT A specimen collecting method comprises an elongate clincicalinstrument comprises a blade and handle for collecting cells and tissuesfrom body cavities, particularly for the detection of squamous carcinomaof the cervix. Two slanted spaced-apart edges on the blade tip describea conical path during manual rotation in situ and gather specimens introughs adjoining the edges. The blade tip is manually separable fromthe handle for forwarding to a pathology laboratory.

2 Claims, 6 Drawing Figures Patented Nov. 27, 1973 L'QJ.

I.\'\'E.\'TOR,

BE RNARD MCDONALD m' A T TORXE Y 1 UTERINE SPECIMEN COLLECTING METHODThis is a continuation-in-part of my patent application Ser. No. 24,535filed Apr. 1, 1970, now US. Pat. No. 3,633,565 issued on Jan. 11, 1972.

This invention concerns a clinical specimen collecting method and morespecifically relates to a method of collecting tissue fragments from thehuman uterus.

Devices commonly used for collection of samples as required fordetection of interuterine cancer or the like typically include simpleswabs, small wood stocks, brushes or else relatively elaborate andcostly aspirators. Since cancer cells are fragile and break or fall awayeasily from any surface supporting them, and since surrounding tissuesusually obscure the test area, it is often difficult to know whethersuch cells which might have been initially resting on a swab of stickwere jarred or rubbed off and lost in the attempt to remove the samefrom the test situs.

The problem associated with specimen collecting in the foregoing contextare notably difficult in the case of squamous carcinoma which mostcommonly originates at the squamo columnar junction. An accuratedetermination of cancer requires a complete survey of the entire testarea, which would involve multiple biopsies, and even those wouldrepresent localized portions rather than a comprehensive sampling of thetotal area. Ideally, fragments of tissue must be recovered representingthe total test situs to permit preparation of histological slides whichretain tissue architecture as opposed to cytology slides which present acollection of isolated cells. Surfaces which merely contact a tissue ina manner of a swab or stick collect only loose particles and not tissuefragments. Moreover, many doctors lack the time and patience to transferevery collected cell and particle from a stick onto a microscopic slide,whereby valuable diagnostic materialmay be lost, resulting in a risk orerroneous conclusion in respect to the patients condition.

Due to the foregoing limitations, many Pap Smears cannot be accuratelydiagnosed or else render only an ambiguous result. Where this is thecase, a surgical procedure called cold conization is typically resortedto. However, this is a relatively major operation requiringhospitalization and general anesthesia. The invention device disclosedherein is designated to bridge this diagnostic gap between the officePap Smear and the hospital cold cone thereby preserving many women fromthe risk of non-detection on one hand or the discomfort, danger andexpense inherent in a major operation.

The specimen collecting method in this case consists of first insertingan elongate tool or implement into the cervical canal, said toolcomprising a handle portion and a blade portion. Blade portion isessentially flat or planar and has a pair of oppositely facing andspacedapart edges adapted to scrape the entire circumference of thesquamo columnar junction area with a deep ploughing action. A storinggroove or trough adjoins each of the edges and receives the samplingsprogressively obtained by the stated edges during rotation of theinstrument. Rotation is accomplished by force manually applied to thehandle portion. Following removal of the implement from the cervicalcanal, force is manually applied to portions of the implement asrequired to break the implement at the location of thinned neck portiontherebetween, after which the blade with the collected matter in thegrooves may be dropped into a biopsy bottle and sent to a laboratory forpathological analysis.

Many of the attendant advantages of this invention will be readilyappreciated as the same becomes better understood by reference to thefollowing detailed description when considered in connection with theaccompanying drawings in which:

FIG. 1 shows a partly fragmented elevational view of the structuredisclosed herein;

FIG. 2 shows a view corresponding to FIG. 1 but with the structurerotated ninety degrees relative thereto;

FIG. 3 shows a tip view looking downward onto. the structure shown inFIGS. 1 and 2;

FIG. 4 shows a cross-sectional view taken along line 44 of FIG. 1;

FIG. 5 shows a cross-sectional view taken along line 55 of FIG. 1; and

FIG. 6 shows a cross-sectional view taken along line 66 of FIG. 1.

Referring now to the drawings wherein like reference charactersdesignate like or corresponding parts throughout, there is illustratedin FIG. 1 an implement, generally designated as reference numeral 10comprises a handle portion 12 and a flat blade portion 14 integrallyformed therewith of a substantially rigid material such as plastic. Theblade portion 14 has oppositely faceing substantially parallel surfaces13 and 15 (more particularly illustrated in FIG. 2) and a structurallyweakened neck portion 17 defined by a traverse groove across bothsurfaces 13 and 15 which result in a reduced cross-sectional thicknessas clearly shown in FIG. 5. The blade portion 14 is an elongate cuttershaped along the sides thereof to correspond generally with the naturalcontours of the cervix of a human uterus as required for maximumeffectiveness in performing its intended function. Thus, the oppositeside contours defined by a pair of thin lips or cutting edges 16 and 18may be seen to diverge from relatively close proximity therebetween neara distal end 19 to a maximum width of a pair of oppositely directedprojections 21 and 23. The edges 16 and 18 thus describe a conical pathwhen the implement 10 is rotated by normal force applied to the handle12. If only one edge were made to function as a specimen collector, thelateral forces on such blade would be unbalanced during rotation ofimplement l0 and its longitudinal axis in the manner described below,whereby two oppositely directed edges are preferred in the symmetricalrelationship sug-' gested by edges 16 and 18. A separate recessed grooveadjoins each of the edges 16 and 18 as suggested by grooves 20, 22respectively, and extends coterminally therewith so as to describe thesame conical path as.

slightly, the preferred arrangement is for the included angle to be fromabout l0to 30 degrees between the edges in that portion between distalend 19 and line 44 in FIG. 1, for example, increasing to about 45 to 60included angle in the flared portion from line 44 to oppositelyextending projections 21 and 23. Of particular importance is the factthat edges 16, 18 are directed in opposite directions as seen in FIGS. 3and 4.

Distal end 19 of implement has a bulbous or mushroom-shaped protuberanceextending therefrom and comprising button or dome connected to end 19 byrecessed shaft 26 of lesser diameter than portion 25. Dome 25 has aperipheral scraping edge thereon, Handle portion 12 may be cylindrical,but in the preferred embodiment has a plurality of longitudinalstrengthening ribs 27 symmetrically arranged about the center axis 28 ofthe handle as seen particularly from FIG. 6.

In operation, implement 10 is initially introduced onto the cervicalcanal with distal end 19 projecting therewithin and with oppositelydirected projections 21 and 23 bearing against the outer surfaces of thesquamo columnar junction. While thus positioned, implement 10 is rotated360 about axis 28, although such rotation could obviously be more thanone complete turn. During the foregoing movement, edges 16 and 18 bearuniformly throughout their length with the surfaces which they contactand which have substantially the same contours as the path defined bythe edges during the stated rotation. The relationship between edges l6,l8 and grooves 20, 22 as discussed above results in a plowing andscraping action whereby edges 16, 18 detach cells, surface tissue andother diagnostic material from the test situs, such material beingchanneled into the mentioned grooves as it is progressively accumulated.During withdrawal of implement 10, additional cells or the like arecaptured by the mild scraping action of the peripheral edge 30 ofprotuberance 25 and retained about recessed shaft portion 26 on distalend 19 of the implement. Thereafter, force is applied through portions12 and 14 as required to fracture completely through groove 17 andseparate the two stated portions. Blade portion 14, with the collectedmatter in grooves 20, 22 is then dropped into a biopsy bottle which issealed and sent to a laboratory for pathological analysis. The biopsybottle contains a fixative composition in a colloidal gel form forpreserving the normal structure of tissues as closely as possible to itscondition during life. If desired, the implement 10 with the collectedmatter in grooves 22 may be placed into the biopsy bottle such that thegroove 17 is in close proximity to the top edge of the bottle. Theimplement 10 may now be rotated about a vertical axis with the groove 17resting on the upper most edge of the biopsy bottle such that theimplement is fractured completely through the groove 17 into twoseparate portions with the blade portion dropping into the biopsybottle.

From the foregoing, it may be seen that the structure and method in thiscase provide a rapid and effective means for collecting diagnosticmatter and with a minimum of specialized skill. The plowing and scrapingaction of blade edges 16, 18 assures complete collection of matterthroughout the entire test area whereby a comprehensive sampling isachieved, and further assures that such matter will include surfacetissue structure rather than loose cells only. The area thus sampled iswider and of greater yield potential than could be accomplished bymultiple biopsies. The tissue sheared from the test surface is shallow,so that pain or post operative bleeding are not encountered in usingimplement 10. Moreover, the procedure can be carried out simply duringthe course of a pelvic examination in a medical ofiice and requires noelaborate medical or hospital surgery equipment.

It should be understood that the foregoing relates to only a preferredembodiment of the invention, and that it is intended to cover allchanges and modifications of the example of the invention herein chosenfor the purposes of the disclosure, which do not constitute departuresfrom the spirit and scope of the invention.

, I claim:

1. The method of collecting tissue fragments from the squamo columnararea of a human uterus, comprising:

contacting said area with a scraping edge of an elongated instrumentadapted to remove tissue fragments therefrom, moving said edge relativeto said area in a path corresponding to the surface contour thereof byrotating a handle on said instrument to remove tissue fragments fromsubstantially all of said area, and

breaking away said edge and tissue fragments from said instrument, bygrasping said handle of said instrument with one hand and a portion ofthd scraping edge of the instrument with the other hand and bending theblade portion in a direction transverse to the longitudinal axis of thehandle until said edge and tissue fragments are broken away and sealingsaid edge and said removed fragments in a sterile container for storage,transit, handling and- /or mailing.

2. The method of collecting tissue fragments as recited in claim 1wherein said edge and tissue fragments are placed in said containerbefore said edge and said fragments are broken away from saidinstrument.

1. The method of collecting tissue fragments from the squamo columnararea of a human uterus, comprising: contacting said area with a scrapingedge of an elongated instrument adapted to remove tissue fragmeNtstherefrom, moving said edge relative to said area in a pathcorresponding to the surface contour thereof by rotating a handle onsaid instrument to remove tissue fragments from substantially all ofsaid area, and breaking away said edge and tissue fragments from saidinstrument, by grasping said handle of said instrument with one hand anda portion of thd scraping edge of the instrument with the other hand andbending the blade portion in a direction transverse to the longitudinalaxis of the handle until said edge and tissue fragments are broken awayand sealing said edge and said removed fragments in a sterile containerfor storage, transit, handling and/or mailing.
 2. The method ofcollecting tissue fragments as recited in claim 1 wherein said edge andtissue fragments are placed in said container before said edge and saidfragments are broken away from said instrument.